Supervisor, Formulation and Fill

SUN PHARMA; Billerica (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

SUN PHARMA seeks an experienced supervisor for a 2nd shift (1:30PM-10:00PM) to lead technicians in the preparation, formulation and dispensing of pharmaceutical products in a clean room. You will drive investigations, CAPAs, deviations and change controls with root cause analysis, while ensuring adherence to cGMPs and SOPs.

Responsibilities include scheduling, batch review, inventory oversight and cross-functional collaboration.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• 6–8 years in pharmaceutical manufacturing.
• Strong verbal, written and interpersonal communication skills.
• High initiative and self-motivation.
• Strong computer skills and regulatory awareness.

Responsibilities

• Supervise second shift technicians in preparation, formulation and dispensing.
• Oversee investigations, CAPAs, deviations and change controls.
• Schedule weekly plans for second shift floor activities.
• Review batch records for compliance with specifications.
• Maintain inventory and order production supplies as needed.
• Utilize SAP, TrackWise and EDMS systems.
• Conduct midyear/yearly performance reviews.

Skills

Verbal and written communication

Team leadership

Aseptic processing

Quality mindset

Education

Bachelor's degree in related field

Equivalent experience

Tools

SAP

TrackWise

EDMS

Job description

Job Summary

This position is a 2nd shift role, 1:30PM - 10:00PM. Supervise and perform regularly the preparation, formulation and dispensing of pharmaceutical products according to our current Good Manufacturing (cGMPs) and utilize Standard Operating Procedures (SOPs) in a clean room environment. Write and complete investigations, CAPAs, deviations and change controls utilizing root cause analysis tools and reporting software.

Job Summary

This position is a 2nd shift role, 1:30PM - 10:00PM. Supervise and perform regularly the preparation, formulation and dispensing of pharmaceutical products according to our current Good Manufacturing (cGMPs) and utilize Standard Operating Procedures (SOPs) in a clean room environment. Write and complete investigations, CAPAs, deviations and change controls utilizing root cause analysis tools and reporting software.

Area Of Responsibility

• Supervise and perform the activities of technicians on the second shift in equipment and component preparation operations; dispensing API and excipients; formulation and filling and capping of parenteral drug products. Also responsible for overseeing the formulation and filling of dermatological drug products.
• Schedule weekly plan of floor activities for technicians on second shift
• Author and track to close investigations, CAPAS, deviations and change controls as required
• Troubleshoot and solve moderate to complex problems related to the equipment, processes; existing or new products
• Oversee inventory control in the production area and order supplies as needed for production to assure no delay in the manufacturing plan
• Use systems like SAP, Track Wise, EDMS etc.
• Evaluate team performance by conducting midyear and yearly reviews
• Review completed batch records to ensure product is made in accordance with specifications
• Review SOPs and Batch Records, and update through DCRs as needed
• Work under limited supervision and follows clearly described procedures
• Other duties as assigned
• Education in Life sciences or technical discipline

Work Conditions

• Lab
• Clean room/controlled classified areas
• Manufacturing/production areas
• Office
• Exposure to noise
• Exposure to Chemical/Biological hazards
• Exposure to non-hazardous chemicals
• Exposure to radiation within NRC limits
• Exposure to/use of syringes and needles
• Must wear scrubs/coveralls, safety glasses, safety shoes, gloves as required

Physical Requirements

• Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, stoop, kneel, crouch or crawl, climb, talk and hear
• Able to operate lab equipment, production equipment and computer/office machines
• Ability to wear Personal Protection Equipment
• Lift up to 50 lbs.

Travel Estimate

Up to 0%

Education and Job Qualification

• Bachelor's degree in related field or equivalent experience
• 6 to 8 years of experience in pharmaceutical manufacturing
• Excellent verbal, written and interpersonal communication skills
• High level of initiative and self-motivation
• Strong computer skills
• Attention to detail
• Ability to plan, prioritize and organize diversified workload
• Team management skills
• Record keeping skills
• Safe chemical handling techniques
• Knowledge of SAP, GMP, GDP, FDA, and OSHA regulations and standards

Experience

• Minimum 2 – 5 years of supervisory or team lead experience
• 5 to 7 years of aseptic processing and aseptic area techniques experience